Instructors: Walter Hauck, Ph.D. and Terry
Hyslop, M.S., the Biostatistics Section, Division
of Clinical Pharmacology, Thomas Jefferson
University, Philadelphia PA.
Course Outline:
What and why
- The concepts of individual and population
bioequivalence
- Contrast to current practice of average
bioequivalence
Criteria
- Brief summary of work in this area
- Description of critera chosen by the FDA
FDA guidances
- Summary of draft and final guidances that
recommend population and/or individual
approaches
Implementing individual and population bioequivalence
- Testing individual and population BE criteria
- Sample size requirements
|
|
About the Instructors: Walter Hauck is
Professor and Head of the Biostatistics Section,
Division of Clinical Pharmacology, Thomas
Jefferson University, Philadelphia PA. He
received his B.S. in Mathematics and Economics
from Carnegie-Mellon University in 1969 and his
M.S. and Ph.D. in Statistics from Harvard
University in 1970 and 1975, respectively. Prior
to Thomas Jefferson, he worked at the Harvard
Medical School, Worcester Polytechnic Institute,
Illinois Cancer Council, Northwestern University
Cancer Center, and the University of California
at San Francisco. He is the author or co-author
of over 140 peer-reviewed papers and has served
as statistical consultant to working groups within
FDA's Office of Pharmaceutical Sciences.
Current research interests include statistical
methods for equivalence trials, generally, and
bioequivalence trials, in particular, application of
equivalence approaches in other contexts, and
clinical pharmacology statistics.
Terry Hyslop is Principal Biostatistician and
Director, Biostatistics Consulting Unit in the
Biostatistics Section, Division of Clinical
Pharmacology, Thomas Jefferson University in
Philadelphia, PA. Terry is co-author with
Francis Hsuan and Daniel Holder of "A small
sample confidence interval approach to
Individual Bioequivalence", Statistics in
Medicine, in press. Their methods have been
recommended for both IBE and PBE in the FDA
statistics guidance.
|